August 2021: FDA a aprobat Nivolumab (Opdivo, Bristol-Myers Squibb Company) for patients with fully resected oesophagus or gastroesophageal junction (GEJ) cancer who have received neoadjuvant chemoradiotherapy and have persistent pathologic disease.
Efficacy was assessed in 794 patients with totally resected (negative margins) esophageal or GEJ malignancies who had residual pathologic disease after concomitant chemoradiotherapy in the CHECKMATE-577 (NCT02743494) randomised, multicenter, double-blind trial. Patients were randomly assigned (2:1) to receive 240 mg of nivolumab or placebo every two weeks for 16 weeks, then 480 mg of nivolumab or placebo every four weeks starting at week 17 for up to one year of treatment.
Disease-free survival (DFS) was the primary efficacy outcome measure. It was defined as the time between randomization and the first recurrence (local, regional, or distant from the primary resected site) date, or death, from any cause, as determined by the investigator prior to subsequent anti-cancer therapy.
In CHECKMATE-577, those who received nivolumab had a statistically significant improvement in DFS when compared to those who received placebo. The median DFS was 22.4 months (95 percent confidence interval: 16.6, 34.0) versus 11 months (95 percent confidence interval: 8.3, 14.3) (HR 0.69; 95 percent confidence interval: 0.56, 0.85; p=0.0003). Regardless of tumour PD-L1 expression or histology, the DFS advantage was seen.
Fatigue, rash, musculoskeletal pain, pruritus, diarrhoea, nausea, asthenia, cough, dyspnea, constipation, decreased appetite, back pain, arthralgia, upper respiratory tract infection, pyrexia, headache, abdominal pain, and vomiting are the most common adverse reactions (incidence 20%) in patients receiving nivolumab.
For adjuvant therapy of resected esophageal or GEJ cancer, the recommended nivolumab dose is 240 mg every 2 weeks or 480 mg every 4 weeks for a total treatment duration of 1 year. Both doses are given as intravenous infusions lasting 30 minutes.
De referinţă: https://www.fda.gov/
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